Clinical Application of Intravenous New Castle Disease Virus - HUJ Oncolytic Virus in the Treatment of Advanced Glioblastoma Multiforme, Soft and Bone Sarcomas and Neuroblastoma Patients, Resistant to Conventional Anti- Cancer Modalities
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
Patients with specific metastatic cancers who failed prior therapeutic regimes will be treated with NDV for at least a year or until disease progression. The study will measure progression-free disease and posits that it will be extended.
详细描述
Present therapeutic regimes have not much improved the survival of patients with metastatic cancer. Therapeutic cancer vaccines are a form of immunotherapy designed to educate the immune system to recognise tumor cells as foreign rather than self. New Castle Virus (NDV) has a long history as a broad system oncolytic that can destroy tumor cells and stimulate the immune system. Up to 30 patients suffering from recurrent, refractory Glioblastoma Multiforme, soft an bone sarcomas and disseminated neuroblastoma will be enrolled in this trial and receive daily doses of NDV at least 5 days a week for a minimum of a year or until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of progressive disease in the above categories evaluated by standard tumor staging.
- •Histologically confirmed diagnosis.
- •Failure of conventional anti- cancer modalities.despite optimal application of all relevant available anti- cancer modalities.
- •Age between 3 and 75 years old.
- •Liver function tests less than twice the normal, renal function no more than 20% reduction and white cell and platelets count no more than 30% reduction.
- •Karnofsky performance status of 50% or greater
- •A written informed consent understood and signed by the patient and by a spouse, parent or guardian. In patients with GBM two signs will be required due to possible alterations of psych and understanding.
排除标准
- •Not fulfilling any of the above criteria
- •Moribund patients or patients with life- expectancy < 3 months
- •Karnofksy performance status < 50%
- •Pregnant or lactating women
- •Active local or systemic infections requiring treatment
- •Patients receiving other investigational agents
- •History of allergy to egg ova-albumin.
- •Co-morbidity or life- threatening clinical condition other than the basic cancer
结局指标
主要结局
Progression-free survival
时间窗: at least 1 year
Measure progression-free survival of patients receiving New Castle Virus
次要结局
未报告次要终点